Arzco Octapolar Esophageal Cardiac Record Cath

Q: What is the product code of K905831?

The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.

FDA 510(k) K905831 · Arzco Medical Electronics, Inc.

Substantially Equivalent

510(k) numberK905831

Submission

Device name: Arzco Octapolar Esophageal Cardiac Record Cath
Applicant: Arzco Medical Electronics, Inc.
Vernon Hills, IL, US
Received: December 31, 1990
Decision date: March 29, 1991
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1220
Specialty: Cardiovascular

Other 510(k)s with product code DRF

510(k)	Device	Applicant	Decision
K252794	Vision-MR Diagnostic CatheterDRF · Traditional	Imricor Medical Systems, Inc.	01/08/2026SE
K250590	MAGiC Sweep EP Mapping CatheterDRF · Traditional	Stereotaxis, Inc.	07/23/2025SE
K250310	VIKING Fixed Curve Diagnostic CatheterDRF · Traditional	Boston Scientific Corporation	06/27/2025SE
K240366	EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional	Boston Scientific Corporation	11/01/2024SE
K233900	Nordica PV Cryo Mapping CatheterDRF · Traditional	Synaptic Medical Corporation	09/06/2024SE
K233397	Cosine-10TM Diagnostic CatheterDRF · Traditional	Medtronic, Inc.	12/02/2023SE
K233207	Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special	Boston Scientific Corporation	10/27/2023SE
K232651	BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special	Boston Scientific Corporation	09/29/2023SE
K230503	Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional	Boston Scientific	04/25/2023SE
K210313	EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional	Shanghai Microport EP Medtech Co., Ltd.	12/30/2022SE

More from Shanghai Microport EP Medtech Co., Ltd.

510(k)	Device	Decision
K904943	Tapscope Esophageal Cardiac Recording StethoscopeBZT · Traditional	04/26/1991SE
K903136	Arzo Tapcath Esophageal Recording CatheterDRF · Traditional	01/18/1991SE

Questions and answers

When was Arzco Octapolar Esophageal Cardiac Record Cath cleared by the FDA?

Arzco Octapolar Esophageal Cardiac Record Cath (K905831) received a 510(k) decision of Substantially Equivalent on March 29, 1991, 88 days after the submission was received.

What is the product code of K905831?

The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.